Status:
COMPLETED
Autologous Bone Marrow Transplant for Children With Acute Myelogenous Leukemia (AML) in First Complete Remission
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief Summary
This study proposes to transfer marker genes (detectable genetic traits or segments of DNA that can be identified and tracked) into aliquots of marrow obtained for Bone Marrow Transplant (BTM) in pati...
Detailed Description
The primary objective of this study was to estimate the continuous complete remission rate at 2 years post transplant for children with AML in first complete remission treated with autologous BMT. Se...
Eligibility Criteria
Inclusion
- Patients aged between 1 and 18 years at diagnosis with acute nonlymphocytic leukemia in first remission are eligible for this protocol.
- Patients enrolled on the AML-87 study in second or subsequent remission are eligible for this protocol.
Exclusion
- Has an HLA-matched, MLC-compatible donor(unless parents and/or patient refuses transplant.
- Diagnosis of FAB M3 or FAB M3v (acute progranulocytic leukemia)
- Life expectancy limited by disease other than leukemia
- Significant cardiac disease (echo shortening fraction \<25% or MUGA scan \<50%)
- Severe renal dysfunction, i.e., creatinine clearance less than 60cc/1.73 m2/min
- Severe restrictive pulmonary disease (FCV less than 40% of predicted)
- Severe hepatic disease (bilirubin greater than 3 mg/dl or SGPT greater than 500IU)
- Severe personality disorder or mental illness
- Previous severe cystitis from cyclophosphamide
- Previous total dose of anthracyclines of \>450 mg/m2
- Sever infection that on evaluation by the PI precludes ablative chemotherapy or successful transplantation
- Previous autologous transplant
- HIV reactivity
- Karnofsky score \<70%
Key Trial Info
Start Date :
March 1 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00667927
Start Date
March 1 1991
End Date
January 1 2008
Last Update
April 28 2008
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105